Gardasil

Indications

Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Gardasil Papillomavirus (HPV) types included in the vaccine:

• Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
• Genital warts (condyloma acuminata) are caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

• Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS).
• Cervical intraepithelial neoplasia (CIN) grade 1.
• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3.
• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3.
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.

Gardasil is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:

• Anal, oropharyngeal, and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58.
• Genital warts (condyloma acuminata) are caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:

• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3.

*Take medication only as directed by a registered medical professional.

Pharmacology

HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Efficacy of Human Papillomavirus Quadrivalent against anogenital diseases related to the vaccine HPV types in humans is thought to be mediated by humoral immune responses induced by the vaccine. However, the exact mechanism of protection is unknown.

Dosage

9 through 14 years:

• 2-dose: 0, 6 to 12 months. If the second dose is administered earlier than 5 months after the first dose, administer a third dose at least 4 months after the second dose.
• 3-dose: 0, 2, 6 months.

15 through 45 years:

• 3-dose: 0, 2, 6 months.

*Take medicine as per the advice of a registered doctor.

Administration

For intramuscular use only. Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Human Papillomavirus Quadrivalent should not be diluted or mixed with other vaccines. After thorough agitation, Human Papillomavirus Quadrivalent is a white, cloudy liquid. Before administration, parenteral drug products should be inspected visually for particulate matter and discoloration. Do not use the product if particulates are present or if it appears discolored. Human Papillomavirus Quadrivalent should be administered intramuscularly in the upper arm’s deltoid region or the thigh’s higher anterolateral area. Syncope has been reported following vaccination with Human Papillomavirus Quadrivalent and may result in falling with injury; observation for 15 minutes after administration is recommended.

Interaction

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines.

Contraindications

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Human Papillomavirus Quadrivalent.

Side Effects

The most common (≥10%) local and systemic adverse reactions reported:

• In girls and women 16 through 26 years of age: injection-site pain (89.9%), injection-site swelling (40.0%), injection-site erythema (34.0 %), and headache ( 14.6%).
• In girls 9 through 15 years of age: injection-site pain (89.3%), injection-site swelling (47.8%), injection-site erythema (34.1%), and headache ( 11.4%).
• In women 27 through 45 years of age: injection-site pain (82.8%), injection-site swelling (23.3%), injection-site erythema (16.9%), and headache (13.6%)
• In boys and men 16 through 26 years of age: injection-site pain (63.4%), injection-site swelling (20.2%), and injection-site erythema (20.7%).
• In boys 9 through 15 years of age: injection-site pain (71.5%), injection-site swelling (26.9%), and injection-site erythema (24.9%).

Pregnancy & Lactation

Pregnancy Category B. Reproduction studies have been performed in female rats at doses equivalent to the recommended human dose and have revealed no evidence of impaired female fertility or harm to the fetus due to Human Papillomavirus Quadrivalent. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Human Papillomavirus Quadrivalent should be used during pregnancy only if needed. It is not known whether Human Papillomavirus Quadrivalent is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Human Papillomavirus Quadrivalent is administered to a nursing woman.

Precautions & Warnings

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Use in Special Populations

• Pediatric Use: Safety and effectiveness have not been established in pediatric patients below 9 years of age.
• Geriatric Use: The safety and effectiveness of Gardasil have not been evaluated in a geriatric population, defined as individuals aged 65 years and over.

Overdose Effects

There have been reports of administration of higher than recommended doses of Gardasil. In general, the adverse event profile reported with overdose was comparable to recommended single doses of Gardasil.

Therapeutic Class

Vaccines, Anti-sera & Immunoglobulin

Storage Conditions

Store refrigerated at 2 to 8°C. Do not freeze. Protect from light. Gardasil should be administered as soon as possible after being removed from refrigeration.